Phase III, multicentre, open study to assess the efficacy and safety profiles of the co-administration of lanreotide Autogel 120 mg (administered via deep subcutaneous injections every 28 days) and pegvisomant 40 to 120 mg per week (administered via subcutaneous route once or twice a week) in acromegalic patients failing to respond to lanreotide Autogel 120 mg

Phase 3

Completed

Conditions: Acromegaly
Gigantism
10021112

Registration Number: NL-OMON30806

Lead Sponsor: Ipsen Pharmaceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Male or female aged between 18 and 75 years inclusive.
2. The patient must have had documentation supporting the diagnosis of
acromegaly, including elevated GH and/or IGF-1 levels.
3. The patient is treated with pegvisomant, because of IGF-1 level remaining
above ULN when treated with somatostatin analogue, on a daily basis for at
least 3 months and has normal (age and sex adjusted) IGF-1 level, or IGF-1
level above ULN after treatment with pegvisomant 30 mg per day,
OR the patient is treated with lanreotide Autogel or octreotide LAR for at
least 6 months including the last 3 months at the highest marketed dose, and
has a serum IGF-1 level above ULN, 28 days after the last injection.
AT THE END OF THE RUN-IN PERIOD
4. The patient has a serum IGF-1 level above 1.2 x ULN, or a serum IGF-1
level between ULN and 1.2 x ULN and a serum GH nadir > 1 µg/L
(assessed by an OGTT), 28 days after the 3rd injection of lanreotide Autogel
120 mg.
5. The patient is diabetic and has a serum IGF-1 level above 1.2 x ULN, 28
days after the 3rd injection of lanreotide Autogel 120 mg.

Exclusion Criteria

1. The patient has undergone pituitary surgery or radiotherapy within 6 months
prior to study entry.
2. It is anticipated that the patient will receive pituitary surgery or radiotherapy
during the study.
3. The patient has a history of hypersensitivity to lanreotide or pegvisomant or
drugs with a similar chemical structure.
4.The patient has already been treated with a somatostatin analogue associated
with a GH antagonist.
5. The patient has received a dopamine agonist within 6 weeks prior to study
entry.
6.The patient has abnormal hepatic function at study entry (defined as AST,
ALT, GGT, AP, PT or total bilirubin above 2 x ULN).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be the percentage of acromegalic patients with<br /><br>normalised (age and sex adjusted) IGF-1 level at the end of the co-treatment<br /><br>period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy endpoints will be:<br /><br>-Serum IGF-1 levels, at each assessment.<br /><br>- Number and percentage of patients with normalised (age and sex adjusted)<br /><br>IGF-1 levels, at each assessment.<br /><br>- Acromegaly symptoms.<br /><br>All these endpoints will be assessed before stopping previous treatment (visit<br /><br>V1),<br /><br>before the run-in period (visit V2), at visit V3, and during the co-treatment<br /><br>period 4<br /><br>weeks after the dose adaptation of pegvisomant (visits V5, V7, V9) and V11.<br /><br><br /><br>- Quality of life assessed at visits V2, V3 and V11.</p><br>